Status:
COMPLETED
Predictors of Asthma Exacerbations in Children
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Asthma
Eligibility:
All Genders
4-6 years
Brief Summary
The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.
Detailed Description
Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk f...
Eligibility Criteria
Inclusion
- Informed consent
- Age \>3 and \<7 years
- Diagnosis of intermittent asthma
- In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
- The ability to perform three reproducible spirometries
- Examination in infection-free interval (\> 4 weeks infection-free)
- Minimum distance to the following asthma medications:
- Short-acting beta 2-agonists: 8 hours
- Ipratropium bromide: 24 hours
- Long-acting beta 2-agonists: 24 hours
- steroids: 4 weeks
- leukotriene antagonist: 4 weeks
Exclusion
- Age older than 6 years or younger than 4
- The inability to perform spirometry
- Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
- Participation in another study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01449435
Start Date
August 1 2011
End Date
July 1 2012
Last Update
April 25 2013
Active Locations (1)
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1
Goethe University Hospital
Frankfurt am Main, Hesse, Germany, 60590